Aminophylline for treatment of postdural puncture headache: A randomized clinical trial.

Abstract

To investigate the efficacy and safety of IV aminophylline for patients with postdural puncture headache (PDPH). We randomly assigned patients to groups receiving either 250 mg IV aminophylline or a placebo within 3 hours of symptom onset once daily for 2 consecutive days. The primary endpoint was headache severity 8 hours after treatment. We assessed this using visual analog scale (VAS) scores taken from patients in a standing position. We also recorded posttreatment VAS score changes, Patient Global Impression of Change (PGIC) scores, and adverse events. We performed an intention-to-treat analysis. We enrolled 126 patients with PDPH at 5 centers in China (62 assigned to the aminophylline group and 64 to the placebo group). The median age was 37 years, and 96 (76.2%) patients were women. Compared to the placebo-treated patients, the aminophylline-treated patients had significantly lower mean VAS scores 8 hours after treatment (5.34 vs 2.98, <i>p</i> < 0.001) and were significantly more likely to report improvements on the PGIC (39.1% vs 72.6%, <i>p</i> < 0.01). This therapeutic effect was already evident at the 30-minute time point and persisted for 2 days. There was no significant difference in the incidence of adverse events (4.8% vs 1.6%, <i>p</i> = 0.589). IV aminophylline is an effective and safe early-stage treatment for patients with PDPH. NCT02522013. This study provides Class I evidence that for people with PDPH, IV aminophylline reduces headache severity.